Biostatistics & Reporting · H1ST-AI-STAT-004
SDTM/ADaM, Define.xml, TLFs & analytics.
The problem this family owns
This is the stretch of the trial where the work is repetitive, deadline-bound, and unforgiving of small errors — the part a stretched team feels first, and the part where a missed detail is most expensive to fix later.
The Statistical Programming family puts a purpose-built agent on each of these. You stay in control of every output — the agents absorb the grind, not the judgment.
Where it fits
The biostatistics workhorse. Statistical Programming builds submission-ready CDISC datasets and Define.xml, validates them clean in Pinnacle 21, generates Tables/Listings/Figures, and adds predictive analytics and automated narratives.
It sits in the Biostatistics & Reporting suite — submission-ready datasets, outputs, and reports — and is delivered as 6 individually-deployable AI agents you can adopt one at a time or as a complete workflow.
The agents
Each agent below removes a specific piece of that grind. Deploy the whole family as one workflow, or add the single agent that hurts most today and expand from there.
Transforms raw and collected clinical data into submission-ready SDTM and ADaM datasets across all standard domains with controlled terminology applied.
Learn moreGenerates complete, conformant Define-XML v2.1 metadata and the accompanying Reviewer's Guide directly from your SDTM and ADaM datasets.
Learn moreRuns Pinnacle 21 conformance validation on your SDTM and ADaM datasets and explains every finding in plain, actionable language.
Learn moreProduces submission-quality tables, listings, and figures from ADaM datasets using a library of 100+ CDISC- and FDA-standard output templates.
Learn moreForecasts enrollment, retention, and outcome trends and surfaces early safety and efficacy signals through an explainable risk dashboard.
Learn moreDrafts study and results narratives and executive summaries grounded in your actual TLFs and datasets, ready for statistician review.
Learn moreOne workflow, not point tools
Enabled together, the Statistical Programming agents hand off in sequence — each one's output becomes the next one's input, so nothing is re-keyed and nothing falls between the seams.
Transforms raw and collected clinical data into submission-ready SDTM and ADaM datasets across all standard domains with controlled terminology applied.
Generates complete, conformant Define-XML v2.1 metadata and the accompanying Reviewer's Guide directly from your SDTM and ADaM datasets.
Runs Pinnacle 21 conformance validation on your SDTM and ADaM datasets and explains every finding in plain, actionable language.
Produces submission-quality tables, listings, and figures from ADaM datasets using a library of 100+ CDISC- and FDA-standard output templates.
Forecasts enrollment, retention, and outcome trends and surfaces early safety and efficacy signals through an explainable risk dashboard.
Drafts study and results narratives and executive summaries grounded in your actual TLFs and datasets, ready for statistician review.
Built for regulated trials
Every agent runs inside a validated, audit-ready platform aligned to the standards clinical teams and inspectors expect.
Electronic records and signatures with full audit trails, access controls, and validation.
Good Clinical Practice, including risk-based quality management and computerized-system expectations.
Standards-based data capture, tabulation, and analysis datasets that validate clean in Pinnacle 21.
PHI safeguards, de-identification, and role-based access across the platform.
Lawful processing, data-subject rights, and EU data-residency support for global trials.
Security, availability, and confidentiality controls audited against Trust Services Criteria.
Certified information-security management system governing the whole platform.
AI management system for responsible, governed, and auditable use of AI.
Straight answers
Pulled from the questions teams ask most about the agents in this family — answered plainly, including where the honest answer is a limit.
No pitch, no pressure — a working walkthrough on your own workflow and honest answers, including on the limits. Bring the study that worries you most.
